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HSA Approval

COLPERMIN CAPSULE 187mg

SIN13034P

COLPERMIN CAPSULE 187mg

COLPERMIN CAPSULE 187mg

November 4, 2004

WELLCHEM PHARMACEUTICALS PTE LTD

WELLCHEM PHARMACEUTICALS PTE LTD

Regulatory Information

WELLCHEM PHARMACEUTICALS PTE LTD

WELLCHEM PHARMACEUTICALS PTE LTD

Therapeutic

General Sale List

Formulation Information

CAPSULE, ENTERIC COATED

**How do you use Colpermin®?** Adult, adolescents aged 15 and above. Unless otherwise prescribed by your doctor, one capsule three times a day, ½ to 1 hour before meals on an empty stomach, with a little liquid. This dosage may be increased to two capsules three times a day if discomfort is severe. The medication should be continued until the symptoms have disappeared. This is normally the case within 1–2 weeks. Please inform your doctor or pharmacist if the symptoms do not subside within the stated time. The capsule should not be broken or chewed, otherwise peppermint oil released could produce symptoms of irritation, especially heartburn. Keep to the dosage given in the package leaflet or prescribed by your doctor. If you think that the medicinal product is having too weak or too strong an effect, please talk to your doctor or pharmacist.

ORAL

Medical Information

**What is Colpermin® and how is it used?** The active constituent of Colpermin is natural peppermint oil, which is obtained from the overground parts of Mentha Piperita L (peppermint). Colpermin capsules contain peppermint oil, with its chief constituent, menthol, embedded in a paste-like base. Colpermin has a relaxing, antispasmodic effect on the bowel muscles in hyperirritability of the bowel, especially of the large bowel (irritable colon), and in bowel spasm, particularly large-bowel spasm. The relaxing effect of peppermint oil prevents unpleasant sensation of fullness and bloating, and facilitates the passing of bowel gases. Accompanying cramp-like pains are thus relieved. In order for the peppermint oil to be able to take effect locally in the bowel, cach capsule is coated with a gastric acid-resistant protective film, which prevents premature release of the peppermint oil in the stomach. Colpermin is intended for the relief of symptoms of irritable bowel syndrome.

**When must Colpermin® not be used at all or only with caution?** Colpermin must not be used in cases of known hypersensitivity to peppermint oil, especially menthol, or to any of the excipients listed in the composition. Colpermin should not be used in cases of bile duct obstruction, gallbladder inflammation or liver damage. In adolescents or children under 15 years of age, Colpermin should be administered only if expressly prescribed by a doctor. Administration at the same time as products for heartburn or when there is a deficiency of hydrochloric acid in the stomach should be avoided. Please tell your doctor or pharmacist if you - have any other illnesses - have allergies - are taking other medicinal products (including over-the-counter ones). Please consult a doctor before use if it is the first presentation of symptoms for confirmation of irritable bowel syndrome.

A03A

治疗功能性肠道疾病的药物

Manufacturer Information

WELLCHEM PHARMACEUTICALS PTE LTD

SwissCo Services AG

Tillotts Pharma AG

Active Ingredients

PEPPERMINT OIL

187mg

Peppermint oil

Documents

Patient Information Leaflets

Colpermin PIL.pdf

Approved: November 4, 2004

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